NCT03957486

Brief Summary

The primary purpose of this study is to investigate the effect of arterial cannulation on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

May 17, 2019

Last Update Submit

May 9, 2021

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • difference between SpHb value and SaHb value (SpHb - SaHb) in g/dL

    SpHb value (g/dL) is measured by co-oxymetry, and SaHb value (g/dL) is measured by blood sampling.

    3 time points from the start of anesthesia to the end of anesthesia, an average 2 hours

Study Arms (2)

Same group

EXPERIMENTAL

arterial cannulation on same arm of continuous hemoglobin monitoring

Other: arterila cannulation on same arm

Different group

PLACEBO COMPARATOR

arterial cannulation on different arm of continuous hemoglobin monitoring

Other: arterila cannulation on different arm

Interventions

arterila cannulation on same armOTHER

arterila cannulation on same arm receiving continous hemoglobin monitoring

Same group
arterila cannulation on different armOTHER

arterila cannulation different arm receiving continous hemoglobin monitoring

Different group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopic gastrectomy under general anesthesia

You may not qualify if:

  • atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 21, 2019

Study Start

May 14, 2019

Primary Completion

June 26, 2019

Study Completion

June 26, 2019

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

KR(1)